Safety and Efficacy Study of Cylindrical Abdominoperineal Resection to Treat Rectal Cancer

November 26, 2013 updated by: Zhen Jun Wang, Beijing Chao Yang Hospital

A Randomized, Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Cylindrical Abdominoperineal Resection in the Treatment of Advanced Very Low Rectal Cancer

The purpose of this study is to determine whether cylindrical abdominoperineal resection is effective in the treatment of advanced very low rectal cancer

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Abdominoperineal resection (APR) is still a common operation in patients with tumours less than 6 cm from the anal verge. The perineal phase of APR is a difficult part of the operation, often done with the patient in the supine position.The risk of inadvertent bowel perforation is high, the resulting specimen frequently has a waist at the lower border of the mesorectum, and the circumferential resection margin (CRM) is often close to the rectal muscle tube. The cylindrical APR may be performed via an extended posterior perineal approach, that aims to create a more cylindrical specimen without a waist. The potential benefit of this technique is a reduction in the risk of bowel perforation and tumour involvement of the CRM, and thus in the risk of local recurrence.

Perineal wounds in patients following APR are at considerable risk for infection, dehiscence and delayed healing when closed primarily. This can be further increased in patients who have received neoadjuvant chemoradiation therapy. The adoption of extended resection, such as the cylindrical APR, may cause additional risks. The use of acellular biomaterials, including human acellular dermal matrix (HADM) has drawn great interest for the complex abdominal wall reconstruction.

The purpose of this study is to determine whether cylindrical abdominoperineal resection is effective in the treatment of advanced very low rectal cancer, and to determine the initial results of pelvic reconstruction using human acellular dermal matrix after cylindrical abdominoperineal resection.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Zhen Jun Wang, M.D.
  • Phone Number: 86-013601393711
  • Email: wang3zj@sohu.com

Study Contact Backup

  • Name: Jia Gang Han, M.D.
  • Phone Number: 86-013522867841
  • Email: wzhj611@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Beijing luhe hospital
        • Contact:
        • Principal Investigator:
          • Jian Hua Cai, M.D.
      • Beijing, Beijing, China, 100020
        • Recruiting
        • General Surgery, Beijing Chao Yang Hospital
        • Contact:
        • Principal Investigator:
          • Zhen Jun Wang, M.D.
        • Sub-Investigator:
          • Jia Gang Han, M.D.
        • Sub-Investigator:
          • Hua Chong Ma, M.D.
        • Sub-Investigator:
          • Yan Fu Du, M.D.
        • Sub-Investigator:
          • Min Zhe Li, M.D.
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • The First Affiliated hospital of Zhengzhou University
        • Contact:
          • Wei Tang Yuan, M.D.
          • Phone Number: 86-013673384555
        • Principal Investigator:
          • Wei Tang Yuan, M.D.
    • Hubei
      • Wuhan, Hubei, China, 430077
        • Recruiting
        • Zhongnan Hospital, Wuhan University
        • Contact:
          • Qun Qian, M.D.
          • Phone Number: 86-013517110773
        • Principal Investigator:
          • Qun Qian, M.D.
    • Liaoning
      • Shenyang, Liaoning, China, 110002
        • Recruiting
        • Shenyang Anorectal Hospital
        • Principal Investigator:
          • Xian Dong Zeng, M.D.
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Shandong Cancer Hospital and Institute
        • Contact:
          • Heng Ma, M.D.
          • Phone Number: 86-013954191086
        • Principal Investigator:
          • Heng Ma, M.D.
      • Jinan, Shandong, China, 250022
        • Recruiting
        • General Surgery, Shandong Provincial Hospital
        • Contact:
          • Yong Dai, M.D.
          • Phone Number: 86-013708933989
        • Principal Investigator:
          • Yong Dai, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

hospitalized patients with rectal cancer

Description

Inclusion Criteria:

  • Tumor within 6 cm of the anal verge, or with very narrow pelvis
  • T3-T4 as determined by preoperative MRI or endorectal ultrasonography examination, or a low tumor is fixed or tethered at rectal examination
  • Absence of distant metastases
  • Absence of intestinal obstruction

Exclusion Criteria:

  • T1-T2 as determined by preoperative MRI or endorectal ultrasonography examination
  • with distant metastases
  • with intestinal obstruction
  • pregnancy or lactation
  • allergic constitution to heterogeneous protein
  • with operation contraindication
  • with mental disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cylindrical abdominoperineal resection
patients underwent cylindrical abdominoperineal resection for advanced very low rectal cancer
Procedure: cylindrical abdominoperineal resection
Extended abdominoperineal resection with human acellular dermal matrix reconstruction of the pelvic floor for rectal cancer
Other Names:
  • Ruinuo
abdominoperineal resection
patients underwent conventional abdominoperineal resection for advanced very low rectal cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative complications
Time Frame: 08/01/2011
08/01/2011

Secondary Outcome Measures

Outcome Measure
Time Frame
3-years overall survival
Time Frame: 08/01/2013
08/01/2013

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Chao Yang Hospital

Collaborators

Wuhan University
Shandong Provincial Hospital
Shandong Cancer Hospital and Institute
The First Affiliated Hospital of Zhengzhou University
Beijing Luhe Hospital
Shenyang Anorectal Hospital

Investigators

  • Study Chair: Zhen Jun Wang, M.D., Beijing Chao Yang Hospital
  • Principal Investigator: Xian Dong Zeng, M.D., Shenyang Anorectal Hospital
  • Principal Investigator: Yong Dai, M.D., Shandong Provincial Hospital
  • Principal Investigator: Heng Ma, M.D., Shandong Cancer Hospital and Institute
  • Principal Investigator: Qun Qian, M.D., Zhong Nan Hospital, Wuhan University
  • Principal Investigator: Jian Hua Cai, M.D., Beijing luhe hospital
  • Principal Investigator: Wei Tang Yuan, M.D., The First Affiliated hospital of Zhengzhou University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Anticipated)

November 1, 2013

Study Completion (Anticipated)

November 1, 2013

Study Registration Dates

First Submitted

July 29, 2009

First Submitted That Met QC Criteria

July 29, 2009

First Posted (Estimate)

July 30, 2009

Study Record Updates

Last Update Posted (Estimate)

November 28, 2013

Last Update Submitted That Met QC Criteria

November 26, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAPR0668

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Complications

Clinical Trials on cylindrical abdominoperineal resection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe